Trends, challenges and priorities

The in-line monitoring and real-time release (ILM/RTR) adoption program focuses on the operational system innovation needed to describe how a factory of the future will work. It also provides an umbrella for all activities relating to adoption of the ILM/RTR technology roadmap that formed part of the first edition of the BioPhorum technology roadmap. ILM/RTR adoption requires a significant collaborative effort from biomanufacturers, suppliers and regulatory agencies.

The program coordination team made up of thought leaders and subject matter experts has the backing of a wider interest group acting as a sounding board and providing a layer of governance. Key contacts have been established with all relevant BioPhorum workstreams. Together, they are committed to a three-year phased plan for delivery.

The priority for the program is to support the business requirements for adoption, and the team has now developed an operational vision. Taking a technology-agnostic approach, the vision articulates the beginning, middle and aspirational future states for adoption and a high-level sequence for implementation of ILM/RTR. This is important as it starts to describe how a factory of the future will operate and how organizations might stage their investment to get there from their current state.

Across BioPhorum, all workstreams are working on new, faster or improved methods, controls and processes that will each drive the industry closer to the goal, including two proof of concept exercises in BioPhorum Technology Roadmapping.

In 2022, the program coordination team will present the vision for adoption of ILM/RTR and start work on phase two, which will address the extent of change required not only to processes and technology, but also the people involved in the industry and its partners.

For this reason, the partnership with regulatory governance is particularly important, providing a single voice to engage with external partners. Of note, the team shared their perspectives and had several key deliverables throughout the past year, including the publication industry proposal for the registration and lifecycle management of manufacturing models, the response to the Danish medicine agency on AI/ML in GxP environment, as well as sharing at the CASSS 2021 conference.

ILM / RTR deliverables November 2021 to November 2022

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